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Talk to a SpecialistTalk to a SpecialistOne Roof LLC, a ready-to-eat food manufacturer in Baltimore, Maryland, was cited for serious violations of Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls regulations in the production of Dark Chocolate Walnut Cookies and Spider Web Tarts. The FDA determined these products were adulterated because they were prepared under insanitary conditions that could have resulted in contamination with filth or rendered them injurious to health, and the company failed to comply with preventive controls provisions required under 21 CFR Part 117. Additionally, the products were found to be misbranded due to significant labeling violations, including an undeclared almond allergen that prompted a voluntary recall on October 21, 2024. The warning followed an FDA inspection conducted from October 24 through December 9, 2024, initiated as a follow-up to the voluntary recall.